TrueDent

Basic Information

• Brand Name: TrueDent
• Primary DI: 07290018915400
• Version / Model: TrueDent Cyan
• Company Name: STRATASYS LTD
• Labeler DUNS: 532091048
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-06
• Public Version: 1
• Public Version Date: 2023-03-14
• Public Version Status: New
• Public Device Record Key: abc48595-8249-47c3-a873-fee22ec9790a

Device Description

Stratasys TrueDent™ is Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work. Fabrication of dental appliances with Stratasys TrueDent™ requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, a Stratasys PolyJet 3D printer, and curing light equipment.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290018915400	GS1

Premarket Submissions

Submission Number	Supplement Number
K220771	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in temperatures between 15°C and 27°C, in a cool, well ventilated, dry area away from potential sources of heat, open flames, sunlight or other chemicals. Store in a combustible storage area.